CytRx Corporation Reports 2018 Financial Results
LOS ANGELES, March 29, 2019 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced financial results for the full year ended December 31, 2018 and provided an overview of recent accomplishments and plans for its research and development programs.
"During late 2018 and early 2019, our core focus has been on working to secure a strategic partnership for our albumin binding ultra high potency LADR(TM) (Linker Activated Drug Release) assets and the accompanying albumin companion diagnostic (ACDx)," said Eric Curtis, CytRx's President and Chief Operating Officer. "As part of that effort, we have been publishing and raising awareness around the important data generated by Dr. Felix Kratz and his team. With the conclusion of the LADR(TM) pre-clinical phase in late 2018, our cash burn has been significantly reduced, allowing for a longer runway as we work to execute on our corporate objectives. In parallel, we are pleased to see positive momentum by our asset licensees, NantCell and Orphazyme A/S.
Fourth Quarter 2018 and Recent Highlights
Centurion BioPharma Corporation
-- ACDx Manuscript Published in the Journal Nuclear Medicine and Molecular
Imaging. In March 2019, peer reviewed, scientific research for
Centurion's ACDx was published online in the journal Nuclear Medicine
and Molecular Imaging. The manuscript, titled "Development of a Novel
Imaging Agent for Determining Albumin Uptake in Solid Tumors," can be
accessed and purchased online at
https://doi.org/10.1007/s13139-019-00587-w.
-- LADR-7 Scientific Research Published as Cover Story in the Journal of
Controlled Release. In February 2019, peer reviewed, scientific research
for LADR-7 (AE-Keto-Sulf07), one of Centurion's lead LADR(TM)
candidates, was published as a cover story in the Journal of Controlled
Release, a leading journal for drug delivery. The article, titled "Novel
auristatin E-based albumin-binding prodrugs with superior anticancer
efficacy in vivo compared to the parent compound," can be accessed and
purchased online at
https://www.sciencedirect.com/journal/journal-of-controlled-release/vol/
296.
-- Highlighted Important OncLive® Article Citing Majority of Cancer
Patients Do Not Have Targetable Genetic Mutations. In February 2019,
Centurion highlighted an OncLive® article citing that 65% of oncology
patients do not have targetable genetic mutations that would make them
eligible for targeted treatment and are therefore candidates for
chemotherapy. Centurion's core focus is on developing its LADR(TM) drug
candidates, which have the potential to improve efficacy and safety of
cytotoxics by targeting ultra-high potency drug delivery directly inside
the tumor.
-- Concluded Pre-Clinical Phase for Albumin Binding Ultra High Potency
LADR(TM) Drug Candidates and Accompanying Companion Diagnostic. In
December 2018, the Company concluded the pre-clinical phase of
development for its albumin binding ultra high potency LADR(TM) drug
candidates, LADR-7, LADR-8, LADR-9 and LADR-10, and for its unique ACDx.
The critical preclinical steps were achieved and each of these pipeline
assets are now eligible for IND-enabling studies. As a result, Centurion
reduced its cash burn and will utilize its financial resources for other
opportunities while working to secure a strategic transaction for the
LADR(TM) and ACDx assets, with the goal of executing such a transaction
as soon as possible.
-- Highlighted Certain Key Emerging Oncology Trends Which Strengthen the
Potential of the Rationally Designed LADR(TM) Assets. In October 2018,
the Company highlighted that key emerging cancer treatment trends by big
pharma, including combining immunotherapy with effective chemotherapy
regimens, are resulting in significant advancements for the treatment of
patients with high unmet medical need types of cancer. The Company
believes these trends strengthen and enhance the value proposition for
their rationally designed, albumin binding ultra-high potency LADR(TM)
assets. Collectively the SITC data showed that Nant Cancer Vaccine (NCV)
therapy is well tolerated with encouraging early signals of efficacy.
CytRx Corporation
-- Arimoclomol Licensee Orphazyme A/S Reports Positive Phase 2/3 Clinical
Data in Niemann Pick Disease Type C (NPC). In February 2019, CytRx
highlighted positive Phase 2/3 clinical trial data reported by
arimoclomol licensee Orphazyme A/S (CPH: ORPHA) in NPC. In this full
data set analysis, arimoclomol showed a 74% reduction in disease
progression after 12 months compared to placebo control
(p-value=0.0506), the primary endpoint of the trial. Should arimoclomol
be approved for NPC in the U.S. and Europe, CytRx is eligible to receive
$10 million in milestone payments, plus royalties.
-- Aldoxorubicin included in New NantCell Inc. Colorectal Cancer Clinical
Trial. In January 2019, CytRx highlighted that aldoxorubicin licensee
NantCell, Inc., has dosed the first patient in the Phase 1b portion of a
Phase 1b/2 clinical trial for patients with relapsed or refractory
colorectal cancer (CRC) who have been previously treated with standard
of care (SOC) therapy. This is the fourth trial conducted by NantCell
which will investigate high-affinity natural killer (haNK) cell therapy
in combination with anti-cancer agents, including aldoxorubicin, in
certain high unmet need cancer indications.
-- NantCell Inc's Presented Aldoxorubicin Clinical Data at the Society for
Immunotherapy of Cancer (SITC)'s 33rd Annual Meeting. In November 2018,
CytRx highlighted two poster presentations by aldoxorubicin licensee
NantCell, Inc. at SITC. The presentations describe positive safety and
efficacy data from the Phase 1b portion of Phase 1b/2 clinical trials
evaluating NantCell's high-affinity natural killer (haNK) cell therapy
in combination with anti-cancer agents, including aldoxorubicin, in
patients with third-line or greater triple negative breast cancer
(TNBC), fourth-line or greater head and neck squamous cell carcinoma
(HNSCC) or recurrent metastatic pancreatic cancer.
Full Year 2018 Financial Results
CytRx reported cash and cash equivalents of $21.4 million as of December 31, 2018.
With the closing of the Freiburg lab operations, CytRx treated the expenses of those operations as discontinued operations in both 2018 and 2017.
Net loss for the year ended December 31, 2018, was $12.7 million, or $(0.41) per share, compared with a net loss of $35.0 million, or $(1.46) per share, for the comparative 2017 period, a reduction of $22.2 million, or approximately 63 percent. This included a loss from discontinued operations of $3.6 million in 2018 as compared to $4.5 million in 2017.
Research and development (R&D) expenses were minimal for 2018 as compared to $15.8 million for 2017.
General and administrative (G&A) expenses were $8.1 million for 2018 compared with $12.5 million for 2017. G&A expenses decreased by approximately 35 percent primarily due to a decrease in professional fees and a reduction in employees.
Based on our currently projected expenditures for the year, we have reduced our burn rate to approximately $500,000 per month.
About CytRx Corporation
CytRx Corporation (NASDAQ: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics to treat patients with cancer. CytRx's most advanced drug conjugate, aldoxorubicin, is an improved version of the widely used anti-cancer drug doxorubicin and has been out-licensed to NantCell, Inc. In addition, CytRx's other drug candidate, arimoclomol has been out-licensed to Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA). Orphazyme is testing arimoclomol in four indications including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx Corporation's website is www.cytrx.com.
About Centurion Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that is designed to transform solid tumor treatment. This transformational strategy combines a portfolio of novel, anti-cancer drug candidates that employ LADR(TM) (Linker Activated Drug Release) technology, a discovery engine designed to leverage Centurion's expertise in albumin biology and linker technology for the development of a new class of breakthrough anti-cancer therapies with a unique albumin companion diagnostic (ACDx) that can help identify patients who are most likely to benefit from treatment with the LADR(TM)-derived therapies. A critical element of the LADR(TM) platform is its ability to bind anti-cancer molecules to circulating albumin, the most ubiquitous protein in human blood plasma, and then to release the highly potent cytotoxic payload at the tumor site. This technology allows for the delivery of higher doses of drug directly to the tumor, while avoiding much of the off-target toxicity observed with the parent molecules. Centurion BioPharma Corporation's website is www.centurionbiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties relating to the ability of Centurion BioPharma to enter into strategic transactions or partnerships involving its proprietary LADR(TM) drug candidates; the ability of Centurion's LADR(TM) drug candidates to enter clinical trials or obtain regulatory approvals for any such products; the efficacy, safety and results of any clinical trials involving Centurion's LADR(TM) drug candidates; the ability of Centurion to develop new ultra-high potency drug candidates based on its LADR(TM) technology platform and attract potential licensees; the ability of NantCell to obtain regulatory approval, manufacture and commercialize its products and therapies that use aldoxorubicin; the ability of NantCell to enroll additional patients in clinical trials for aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantCell; the ability of Orphazyme A/S to obtain regulatory approval for, manufacture and commercialize its products and therapies that use arimoclomol; the results of future clinical trials involving arimoclomol; the amount, if any, of future milestone and royalty payments that we may receive from Orphazyme A/S; and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
cytrx@argotpartners.com
CYTRX CORPORATION
CONSOLIDATED BALANCE SHEETS
December 31,
2018 2017
---
ASSETS
Current assets:
Cash and cash
equivalents $21,373,273 $37,497,691
Receivables 148,527 7,504,756
Prepaid expenses
and other current
assets 913,162 1,914,077
Current assets
held for sale 81,182 169,989
---
Total current
assets 22,516,144 47,086,513
Equipment and
furnishings, net 44,326 71,466
Goodwill 183,780
Other assets 40,642 22,933
Non-current
assets held for
sale 324,853 982,827
---
Total assets $22,925,965 $48,347,519
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $1,234,762 $4,065,998
Accrued expenses
and other current
liabilities 726,191 7,881,766
Deferred revenue 6,924,353
Term loan, net -
current 10,599,795
Warrant
liabilities 527,025
Current
liabilities for
sale 602,713 203,527
---
Total current
liabilities 2,563,666 30,202,464
---
Commitment and contingencies
Stockholders' equity:
Preferred Stock,
$0.01 par value, at December 31,
833,334 shares 2018 and 2017,
authorized, respectively
including 4,167
shares of Series
A Junior
Participating
Preferred Stock;
no shares issued
and outstanding -
Preferred Stock,
$0.01 par value, outstanding at
stated value December 31, 2018
$1,000, 650 and 2017.
shares authorized
of Series B
Convertible
Preferred Shares
at $2.52 per
share, no shares
issued and -
Common stock,
$0.001 par value,
41,666,667 shares
authorized;
33,637,501 and
28,037,501 shares
issued and
outstanding at
December 31, 2018
and 2017,
respectively 33,637 28,037
Additional paid-
in capital 477,192,747 468,969,445
Accumulated
deficit (456,864,085) (450,852,427)
---
Total
stockholders'
equity 20,362,299 18,145,055
---
Total liabilities
and stockholders'
equity $22,925,965 $48,347,519
CYTRX CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31,
2018 2017
---
Revenue:
Licensing revenue $250,000 $100,000
Expenses:
Research and
development 388,841 15,847,722
General and
administrative 8,079,861 12,502,042
Depreciation and
amortization 29,423 106,989
---
8,498,125 28,456,753
---
Loss before other
income (expense) (8,248,125) (28,356,753)
Other income (expense):
Interest income 355,558 365,584
Interest expense (1,715,733) (3,831,211)
Other income (expense),
net 2,676 6,998
Gain on warrant
liabilities 527,025 1,367,777
---
Loss before provision
for income taxes (9,078,599) (30,447,605)
Provision for income
taxes (800) (800)
---
Loss from continuing
operations $(9,079,399) $(30,448,405)
Discontinued operations
(Note 3) (3,634,209) (4,538,027)
---
Net loss $(12,713,608) $(34,986,432)
Basic and diluted loss per share
Continuing operations $(0.29) $(1.27)
Discontinued operations $(0.12) $(0.19)
Total basic and diluted
loss per share $(0.41) $(1.46)
Basic and diluted
weighted average
shares outstanding 30,947,650 24,042,293
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